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***OFFICIAL CYDY/Leronlimab Thread*** (3 Viewers)
- Thread starter This_Guy
- Start date
adonis
Footballguy
I can look at these results and say they're not as good as one would hope. Primary missed significance, but still showed major differences. Other endpoints not mentioned, seems a little odd to have mentioned day 14 twice with different p-values in the NEWS2 section, what about day 7?
However, I can't read the results they did announce and see them as anything but good news. The results, from SAE's to NEWS2 showing statistical significance, is unequivocal good news. You can interpret that maybe other news not announced isn't good, but that's how these all go. This seems to be clearly good news. Gonna just sit back now and see how it unfolds. Maybe we should expect a video from nader and our friendly PR video firm this afternoon.
However, I can't read the results they did announce and see them as anything but good news. The results, from SAE's to NEWS2 showing statistical significance, is unequivocal good news. You can interpret that maybe other news not announced isn't good, but that's how these all go. This seems to be clearly good news. Gonna just sit back now and see how it unfolds. Maybe we should expect a video from nader and our friendly PR video firm this afternoon.
adonis
Footballguy
Polish Hammer
made of glass
Here's the rub on this, as I see it. The improvement in the NEWS2 score is very good, and is statistically significant. Had this been the primary endpoint (as stated above) we'd be spiking the football. Maybe even the FDA would fast-track emergency approval. If this were other typical medical-world stuff it would be a good result even as a secondary. Time and perspective would be on your side.
The problem is we are in a very crowded race right now with lots of competition. These results seem like they should open up a Phase 3 trial pretty easily, and if they put in place a primary endpoint that is the same score, I think it would be reasonable to expect success. But the time frame is so crunched right now that enrollment could be tough. Also as other therapies and strategies are out there - especially for mild to moderate - it's going to be a squeeze game to continue to show significant improvement over the current standard of care.
I guess what I'm trying to say is that LL looks like it really helps this population out. But with so many pressures/demands/competitors right now, there's a possibility that simply isn't good enough to really stand out from the crowd.
The problem is we are in a very crowded race right now with lots of competition. These results seem like they should open up a Phase 3 trial pretty easily, and if they put in place a primary endpoint that is the same score, I think it would be reasonable to expect success. But the time frame is so crunched right now that enrollment could be tough. Also as other therapies and strategies are out there - especially for mild to moderate - it's going to be a squeeze game to continue to show significant improvement over the current standard of care.
I guess what I'm trying to say is that LL looks like it really helps this population out. But with so many pressures/demands/competitors right now, there's a possibility that simply isn't good enough to really stand out from the crowd.
Capella
Footballguy
ChiefD
Footballguy
Dwayne Hoover
Footballguy
The results seem good to me. Let's see how this plays out. Was fully expecting we were probably looking at a phase 3 trial for m/m anyway. Severe critical is where I had been banking on and this seems good enough to stabalize the stock price if not outright improve it in six weeks or so until we get those results.
The Doctor at Montefiore had good things to say, just need some more experts to weigh in. Patience right now.
The Doctor at Montefiore had good things to say, just need some more experts to weigh in. Patience right now.
adonis
Footballguy
Experts won't typically weigh in on press releases. Several who have seen the data offer positive comments, but nothing earth shattering. More is needed than this press release to move the needle apparently.
⚡DEADHEAD⚡
Footballguy
Seeking Alpha will cover this, I'm confident, possibly later today.
Capella
Footballguy
Seems like the pop would come on the EUA but for the life of me I just cannot see that happening - mainly bc the deck is stacked.
adonis
Footballguy
Hopefully this isn't the case. If the full story shows improvement for patients, and is released where enough experts can review it and comment supportively, I would think the FDA would do the right thing uninfluenced by competition. But yeah, emergency approval would be a rare event and basically bypasses all the normal checks and balances for drug approvals. However, with the safety profile of leronlimab, the downside seems to be low while the benefit to patients seems to be shown based on these results.
I’m sure the results say it’s way better than Remdesivir or Hydroxywhatever but it’s a good question about EUA.
Jayrok
Footballguy
The SP movement (lack thereof) seems odd but people are used to his PRs. We all know a hit piece will be out today and it's possible investors are waiting for the inevitable price drop to buy lower.
If (when) the FDA gives approval, there will be no hit pieces to stop it from going higher. Until then, all these PRs are just words. And with them we all know it takes time to decipher what is written. They look good to me but what do I know? FDA approval will take all that out of the picture... but it seems more likely that there will be a phase 3.
That isn't bad news but we all know the SP will take more hits if there is a request for phase 3 instead of outright approval. Such is life with CYDY.
If (when) the FDA gives approval, there will be no hit pieces to stop it from going higher. Until then, all these PRs are just words. And with them we all know it takes time to decipher what is written. They look good to me but what do I know? FDA approval will take all that out of the picture... but it seems more likely that there will be a phase 3.
That isn't bad news but we all know the SP will take more hits if there is a request for phase 3 instead of outright approval. Such is life with CYDY.
Bob Sacamano
Footballguy
It's not bad news, but that doesn't make it news that results in a drug that's going to market anytime soon. And that's what is ultimately going to move the needle.
adonis
Footballguy
Would be nice to get an update on where we're at with uplisting, as well as the Type A meeting with the FDA. No fluff, just data. Have comments been received back from NASDAQ team? Are we still on track? Has the Type A meeting been set? Has an Agenda been set? How many patients have been enrolled to date in the S/C trial? Do we have any idea when the interim analysis there will take place?
ETA: When will the pre-print be available with all the data?
ETA: When will the pre-print be available with all the data?
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adonis
Footballguy
Nader and team must now believe they're cursed. It's basically reverse world for them every time they put out what they believe to be good news that should drive the share price up. Gotta be exhausting
.
A handful of patients didn’t get added to the 163k total. No one cares since Putin stuck his kid.
Jayrok
Footballguy
1. Primary endpoint shows early clinical improvement in symptom score at Day 3 in patients receiving leronlimab.
This is good but day 3 wasn't the primary endpoint. What about a sentence that mentions these patients at day 14? "Improvement in day 3 and continued improvement at day 14 (fully recovered?). We can assume they are better at day 14 if they showed clinical improvement at day 3, but you didn't mention it in the PR, so... will be interpreted as not meeting primary endpoint. Same as last PR.
2. Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (NEWS2).
Even if it is a secondary endpoint, it shows improvements in M/M patients. If this were x number of patients that see this benefit, this means that x number of patients that will not (may not) progress to severe/critical status. That's great, right?
It was said that in phase 2 trials, meeting the primary endpoint isn't a pass or fail. Finding other endpoints is a big deal. It's in phase 3 trials that missing the primary endpoint is pass/fail. Trial stopped if primary isn't met.
Will it get approval? Probably not, but will probably be given authorization for phase 3 trial with specific primary endpoint.
That said... NP stated that "Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Is it possible that they do receive FDA approval for this specific population of Covid patients? I think it is. If not, could they take it to UK and other countries? Why not?
This is good but day 3 wasn't the primary endpoint. What about a sentence that mentions these patients at day 14? "Improvement in day 3 and continued improvement at day 14 (fully recovered?). We can assume they are better at day 14 if they showed clinical improvement at day 3, but you didn't mention it in the PR, so... will be interpreted as not meeting primary endpoint. Same as last PR.
2. Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (NEWS2).
This is great. p < .03 and P < .02 (at day 14) is excellent. Both beat the .05 measuring stick to show statistically significance.
Even if it is a secondary endpoint, it shows improvements in M/M patients. If this were x number of patients that see this benefit, this means that x number of patients that will not (may not) progress to severe/critical status. That's great, right?
It was said that in phase 2 trials, meeting the primary endpoint isn't a pass or fail. Finding other endpoints is a big deal. It's in phase 3 trials that missing the primary endpoint is pass/fail. Trial stopped if primary isn't met.
Will it get approval? Probably not, but will probably be given authorization for phase 3 trial with specific primary endpoint.
That said... NP stated that "Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Is it possible that they do receive FDA approval for this specific population of Covid patients? I think it is. If not, could they take it to UK and other countries? Why not?
Dwayne Hoover
Footballguy
Have to admit I was a little concerned with the m/m results given the delay but the news2 results alone are very good. This is good enough to move this along to a phase 3 and gives time to see the results with the severe critical, which is where I believe they can bank.
This will be overall positive on the coming days, not concerned with stock price today.
This will be overall positive on the coming days, not concerned with stock price today.
djmich
Footballguy
It is crazy, it has to come down the cydy crew has no professional credibility. Based on my experience with them and the clarity of their PR's...I'm not sure they should.
Chaz McNulty
Footballguy
Was the primary endpoint of the study flawed? If over 70% of Placebo patients show clinical improvement at day 14, would 100% of LL patients showing clinical improvement be enough to show a significant endpoint p-value? Especially in such a low patient study.
Bob Sacamano
Footballguy
I doubt that's an interpretation issue. They didn't meet it or they would have said they did.
adonis
Footballguy
Low patient count (86 or so), mild to moderate patients almost all of whom would be fully recovered by day 14 anyway, to make the primary endpoint the day 14 results does seem to be a bit much.
Day 3 results does seem significant, as it's the 3rd day after injection. However, it appears that this wasn't statistically significant, either due to low efficacy, or low # of patients.
But yeah, overall, the NEWS2 data seems good, but i'm still hung up on why there are two day 14 p-values.
ChiefD
Footballguy
This seems like this drug is simply not game changing enough for Covid. If it was, doctors and science folks would be screaming from the rooftops for it. Hence, the market response.
To me, this now turns into a long-play for HIV and cancer. If I had bought in early like a lot of you guys, I'd sell it all and move on. But I'm in it for a bit with the hope that it increases a buck or two so I can at least break even.
To me, this now turns into a long-play for HIV and cancer. If I had bought in early like a lot of you guys, I'd sell it all and move on. But I'm in it for a bit with the hope that it increases a buck or two so I can at least break even.
I’d rather lose all my money. 
beef
Footballguy
beef
Footballguy
Chaz McNulty
Footballguy
None of the drugs that have been approved so far are game changing at all. The thought has been that you can prove that you are better than REM, then you will be approved. Unfortunately, this does not appear to be the case.
Otis
Footballguy
djmich
Footballguy
If this guy is reputable, and it looks like he is, this is a powerful statement:
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
I believe getting statistical significant on NEWS2 is a big deal. I think the the clinical symptom score could be a good indicator, but with the population size and severity of symptoms we're just not going to get statistical significance.
I'm really torn what to do here (hold or buy).
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
I believe getting statistical significant on NEWS2 is a big deal. I think the the clinical symptom score could be a good indicator, but with the population size and severity of symptoms we're just not going to get statistical significance.
I'm really torn what to do here (hold or buy).
Otis
Footballguy
Golf Guy 69
Footballguy
That Jordan Peele movie title keeps popping in my head.
Caesar
Footballguy
Bob Sacamano
Footballguy
lol
Sometimes I think Cav and I might be the same person.
That's more than a little disconcerting.
Sometimes I think Cav and I might be the same person.
That's more than a little disconcerting.
Capella
Footballguy
I thought yahoo was my stock ticker app but I guess it’s Apple. Either way it’s still not on there and I have to imagine that’s the one a lot of Apple users have since it’s native to the phone.
latest is from 4 weeks ago.
https://imgur.com/a/bn1dQeV
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Chaz McNulty
Footballguy
I believe they are really going to have to push this in the UK and EU. That might be their best chance. They should have a team working on this, and not just NP sending them emails.
Charlie Harper
Footballguy
Still have S/C.
Anecdotal evidence, decreased SAEs, and improved NEWS score. This drug is proving it's worth.
#notselling
Charlie Harper
Footballguy
adonis
Footballguy
New (not about today's results) NYT article that metions leronlimab:
long article, relevant section:
long article, relevant section:
⚡DEADHEAD⚡
Footballguy
Dozens of trials are currently underway that focus on the immune system. These involve everything from cheap, over-the-counter pain medication to expensive antibodies manufactured in living cells. The drugs they are testing include anakinra, used by Navarro-Millán; leronlimab, a drug with anti-inflammatory properties originally developed to treat H.I.V.; and drugs that block IL-6 (full disclosure: My wife works for Genentech, owned by Roche, which manufactures tocilizumab, one of the IL-6 blockers).
This is as interesting as the LL mention. If CYDY and LL was huckstery, you'd think he might know this through his wife, and then perhaps not mention it in this article.
This is as interesting as the LL mention. If CYDY and LL was huckstery, you'd think he might know this through his wife, and then perhaps not mention it in this article.
